Alexza Pharmaceuticals announced that it has received a complete response letter from the US FDA in regards to its application for Staccato loxapine inhalation aerosol for the treatment of agitation in schizophrenic and bi-polar patients. The FDA cited concerns about safety based on reductions in FEV 1 seen during Phase I studies and about stability studies performed by Alexza. The Center for Devices and Radiological Health (CDRH) also requested a human factors study for the novel Staccato delivery device. Alexza says that it plans to meet with the FDA as soon as possible to discuss the agency’s concerns. Read the company’s press release.
